← Back to catalogue

Acs

FDA UDI

Class II (US FDA UDI)

by American Contract Systems, Inc.

Identity

Trade Name
ACS FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
DAVINCI SET-UP PACK FDA UDI
Model / Reference
MMDA26I FDA UDI
Description
DAVINCI SET-UP PACK FDA UDI

Identifiers

Primary DI / UDI-DI
00191072114259 FDA UDI
FDA Product Code
FDE FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: General surgical procedure kit, non-medicated, single-use

Acs by American Contract Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
American Contract Systems, Inc.

Sources (1)

  • FDA UDI 0092883e-682a-48df-9524-fd226a8f4851 33 fields · synced May 30, 2026